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The objective of this surveillance is to collect information for panic disorder patients about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
All patients with panic disorder to whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline hydrochloride. | The patients of Panic disorder taking Sertraline hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline hydrochloride | Drug | J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan. Dosage, Frequency: According to Japanese LPD, "The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms". Duration: According to the protocol of A0501092, the duration of the investigation for findings regarding safety and efficacy of a panic disorder patient is from the first drug administration to the 16 weeks after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants of Treatment Related Adverse Events (TRAEs) | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | Baseline up to 52 weeks |
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Baseline up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug |
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Inclusion Criteria:
Patients with panic disorder need to be taking sertraline hydrochloride in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not taking sertraline hydrochloride.
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The patients to whom an investigator involved in A0501092 prescribes sertraline hydrochloride.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline | Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is "patients who are diagnosed with panic disorder". So, all of participants in this study are panic disorder patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline | Participants taking Sertraline according to Japanese Package Insert |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants of Treatment Related Adverse Events (TRAEs) | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline. | Posted | Number | participants | Baseline up to 52 weeks |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertraline | Participants taking Sertraline according to Japanese Package Insert.The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mania | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
|
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) |
| Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | Baseline up to 52 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug | Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor | Baseline up to 52 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Complication | Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | Baseline up to 52 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | Number of participants with responders of Sertraline to determine whether drinking status is significant factor | Baseline up to 52 weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Target Disease Severity | The severity of target disease which was diagnosed by investigator | Number | participants |
|
| Complications | Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | Number | participants |
|
| Concomitant drug | Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) | Number | participants |
|
| Starting dose | Starting dose of each participant enrolled in this study | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | events | Baseline up to 52 weeks |
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug | Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Complication | Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | Number of participants with responders of Sertraline to determine whether drinking status is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| 1 |
| 908 |
| 110 |
| 908 |
| Somnolence | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA/14.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/14.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA/14.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA/14.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA/14.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA/14.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA/14.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA/14.1 | Systematic Assessment |
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| Ejaculation disorder | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
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| Ejaculation failure | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
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| Sexual dysfunction | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA/14.1 | Systematic Assessment |
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| Thirst | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Ventricular extrasystoles |
|